#FutureReadyHealthcare
Achieving Seamless Compliance: Indegene Expedites Remediation of Client's Quality Management System
The Customer
A multinational healthcare services and products company that specializes in the distribution of medical, surgical, and laboratory products. Their offerings include a broad range of medical devices, pharmaceuticals, and clinical products and were exploring assistance in Annual Summary Report (ASR) submission for class IV medical devices in Canada
The Need
Client required a partner to collaborate and develop new Canadian Annual Summary Reports(ASRs) for two Class IV products as per Canadian Medical Devices Regulations (CMDR) (SOR-98-282) with a stringent timeline of 8 weeks.
The ASR document required mapping of 200+ hazards with the product risk management files plus analysis of 100+ complaints from raw data.
The Solution: Highly qualified medical writers and reviewers
A highly qualified team of medical writers and medical reviewers assigned to the project with a goal to meet the 8 weeks turnaround time.
Based on the team’s in-depth knowledge on Canadian Regulations, provided value based inputs to enhance the client’s ASR template.
The team of medical writers and reviewers served as the SMEs for end-to-end ASR authoring, addressing gaps in client’s source documents, and collaborating efficiently with the client’s cross-functional team.
Conducted a very comprehensive literature surveillance review right from defining the search strategy to literature summarization and extraction of data for the hazards and hazardous situations to map to the risk files.
Also, accurately analyzed the complaints data to compile the incidents rate and hazards table for comparison with the product risk management file and categorized 200+ hazards to 60 high level hazards for ease of mapping.
The Outcomes
The partnership with Indegene resulted in a streamlined regulatory process, achieving accuracy and efficiency in both Canadian ASR submissions and EU MDR recertifications. The implementation of efficient project management strategies, regulatory expertise, and the CoE model positioned the customer for productivity enhancement.
25-30%
Productivity enhancement through new process implementation
100%
First Time Right Draft Acceptance
100%
compliance to CMDR (SOR-98-282) requirements
Ready to streamline your regulatory compliance processes? Contact us today to explore how our expertise can fast-track your product’s journey to regulatory compliance.